SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.5 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: SubmittedMedicinalPackaging

Details around the packaging of submitted medicinal products.

Usage:

• Use this Resource Profile: ProductSubmissionBundle
• Refer to this Resource Profile: Packaged Product Reference
• Examples for this Resource Profile: PackagedProductDefinition/Allopurinol100Tablets, PackagedProductDefinition/Allopurinol30Tablets, PackagedProductDefinition/Allopurinol60Tablets, PackagedProductDefinition/Allopurinol90Tablets... Show 15 more, PackagedProductDefinition/Enbrel010Package, PackagedProductDefinition/Enbrel021Package, PackagedProductDefinition/Enbrel032Package, PackagedProductDefinition/Enbrel044Package, PackagedProductDefinition/Enbrel055Package, PackagedProductDefinition/Enbrel425Package, PackagedProductDefinition/Enbrel425Part1Package, PackagedProductDefinition/Enbrel425Part2Package, PackagedProductDefinition/Enbrel435Package, PackagedProductDefinition/Enbrel445Package, PackagedProductDefinition/Enbrel446Package, PackagedProductDefinition/Enbrel455Package, PackagedProductDefinition/Enbrel456Package, PackagedProductDefinition/LantusSyringePackage and PackagedProductDefinition/LantusVialPackage

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
packageFor	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product that this is a pack for ele-1: All FHIR elements must have a @value or children
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
marketingStatus	SΣ	0..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) ele-1: All FHIR elements must have a @value or children
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain ele-1: All FHIR elements must have a @value or children
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap ele-1: All FHIR elements must have a @value or children
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension:packageInstanceOf	S	0..1	Reference(SubmittedMedicinalPackaging)	Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	SΣ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier ele-1: All FHIR elements must have a @value or children
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: SPL Package Types (required) ele-1: All FHIR elements must have a @value or children
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1) ele-1: All FHIR elements must have a @value or children
property	SΣ	0..*	BackboneElement	General characteristics of this item ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: SPL Combo Product Type (required) ele-1: All FHIR elements must have a @value or children
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item	SΣ	1..1	CodeableReference(SubmittedManufacturedItem)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package ele-1: All FHIR elements must have a @value or children
amount	SΣ	1..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) ele-1: All FHIR elements must have a @value or children
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
PackagedProductDefinition.packaging.type	required	SPLPackageTypes http://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypes from this IG
PackagedProductDefinition.packaging.property.type	example	Pattern: SPLCMBPRDTP http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]	required	SPLComboProductType http://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductType from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition			PackagedProductDefinition
packageFor	S	1..1	Reference(SubmittedMedicinalProduct)	The product that this is a pack for
marketingStatus	S	0..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
status	S	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	S	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
packaging	S	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:packageInstanceOf	S	0..1	Reference(SubmittedMedicinalPackaging)	Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf
identifier	S	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	S	1..1	CodeableConcept	The physical type of the container of the items Binding: SPL Package Types (required)
quantity	S	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
property	S	0..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: SPL Combo Product Type (required)
containedItem	S	0..*	BackboneElement	The item(s) within the packaging
item	S	1..1	CodeableReference(SubmittedManufacturedItem)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	S	1..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	S	0..*		Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
PackagedProductDefinition.packaging.type	required	SPLPackageTypes http://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypes from this IG
PackagedProductDefinition.packaging.property.value[x]	required	SPLComboProductType http://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductType from this IG

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	A unique identifier for this package as whole - not for the content of the package
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	Σ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package.
packageFor	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes
marketingStatus	SΣ	0..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
copackagedIndicator	Σ	0..1	boolean	Identifies if the drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type (multiple means these are all possible manufacturers)
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the packaged product
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:packageInstanceOf	S	0..1	Reference(SubmittedMedicinalPackaging)	Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier	SΣ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: SPL Package Types (required)
componentPart	Σ	0..1	boolean	Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material	Σ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components.
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components.
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	SΣ	0..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: SPL Combo Product Type (required)
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item	SΣ	1..1	CodeableReference(SubmittedManufacturedItem)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	SΣ	1..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PackagedProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PackagedProductDefinition.type	example	PackageType http://hl7.org/fhir/ValueSet/package-type from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.code	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PackagedProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
PackagedProductDefinition.packaging.type	required	SPLPackageTypes http://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypes from this IG
PackagedProductDefinition.packaging.material	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterial	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.property.type	example	Pattern: SPLCMBPRDTP http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]	required	SPLComboProductType http://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductType from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 3 elements(3 nested mandatory elements)
Must-Support: 16 elements

Structures

This structure refers to these other structures:

• SubmittedMedicinalProduct (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct)
• SubmittedManufacturedItem (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf

Maturity: 1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
packageFor	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product that this is a pack for ele-1: All FHIR elements must have a @value or children
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
marketingStatus	SΣ	0..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) ele-1: All FHIR elements must have a @value or children
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain ele-1: All FHIR elements must have a @value or children
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap ele-1: All FHIR elements must have a @value or children
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
extension:packageInstanceOf	S	0..1	Reference(SubmittedMedicinalPackaging)	Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	SΣ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier ele-1: All FHIR elements must have a @value or children
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: SPL Package Types (required) ele-1: All FHIR elements must have a @value or children
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1) ele-1: All FHIR elements must have a @value or children
property	SΣ	0..*	BackboneElement	General characteristics of this item ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: SPL Combo Product Type (required) ele-1: All FHIR elements must have a @value or children
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
item	SΣ	1..1	CodeableReference(SubmittedManufacturedItem)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package ele-1: All FHIR elements must have a @value or children
amount	SΣ	1..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) ele-1: All FHIR elements must have a @value or children
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
PackagedProductDefinition.packaging.type	required	SPLPackageTypes http://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypes from this IG
PackagedProductDefinition.packaging.property.type	example	Pattern: SPLCMBPRDTP http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]	required	SPLComboProductType http://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductType from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from PackagedProductDefinition

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition			PackagedProductDefinition
packageFor	S	1..1	Reference(SubmittedMedicinalProduct)	The product that this is a pack for
marketingStatus	S	0..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
status	S	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	S	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
packaging	S	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:packageInstanceOf	S	0..1	Reference(SubmittedMedicinalPackaging)	Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf
identifier	S	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	S	1..1	CodeableConcept	The physical type of the container of the items Binding: SPL Package Types (required)
quantity	S	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
property	S	0..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP
value[x]	S	1..1	CodeableConcept	A value for the characteristic Binding: SPL Combo Product Type (required)
containedItem	S	0..*	BackboneElement	The item(s) within the packaging
item	S	1..1	CodeableReference(SubmittedManufacturedItem)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	S	1..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	S	0..*		Allows containers (and parts of containers) within containers, still as a part of single packaged product
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
PackagedProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
PackagedProductDefinition.packaging.type	required	SPLPackageTypes http://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypes from this IG
PackagedProductDefinition.packaging.property.value[x]	required	SPLComboProductType http://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductType from this IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
PackagedProductDefinition		0..*	PackagedProductDefinition	A medically related item or items, in a container or package
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	A unique identifier for this package as whole - not for the content of the package
name	Σ	0..1	string	A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
type	Σ	0..1	CodeableConcept	A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package.
packageFor	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product that this is a pack for
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
containedItemQuantity	Σ	0..*	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
description	Σ	0..1	markdown	Textual description. Note that this is not the name of the package or product
legalStatusOfSupply	Σ	0..*	BackboneElement	The legal status of supply of the packaged item as classified by the regulator
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	0..1	CodeableConcept	The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes
marketingStatus	SΣ	0..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
copackagedIndicator	Σ	0..1	boolean	Identifies if the drug product is supplied with another item such as a diluent or adjuvant
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package type (multiple means these are all possible manufacturers)
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the packaged product
packaging	SΣ	1..1	BackboneElement	A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:packageInstanceOf	S	0..1	Reference(SubmittedMedicinalPackaging)	Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier	SΣ	0..*	Identifier	An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
type	SΣ	1..1	CodeableConcept	The physical type of the container of the items Binding: SPL Package Types (required)
componentPart	Σ	0..1	boolean	Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
quantity	SΣ	0..1	integer	The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
material	Σ	0..*	CodeableConcept	Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components.
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components.
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this packaging item (multiple means these are all potential manufacturers)
property	SΣ	0..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic Binding: SPL Combo Product Type (required)
containedItem	SΣ	0..*	BackboneElement	The item(s) within the packaging
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
item	SΣ	1..1	CodeableReference(SubmittedManufacturedItem)	The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
amount	SΣ	1..1	Quantity	The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
packaging	SΣ	0..*	See packaging (PackagedProductDefinition)	Allows containers (and parts of containers) within containers, still as a part of single packaged product
characteristic	Σ	0..*	See property (PackagedProductDefinition)	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
PackagedProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
PackagedProductDefinition.type	example	PackageType http://hl7.org/fhir/ValueSet/package-type from the FHIR Standard
PackagedProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.code	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
PackagedProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
PackagedProductDefinition.packaging.type	required	SPLPackageTypes http://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypes from this IG
PackagedProductDefinition.packaging.material	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterial	example	PackageMaterial http://hl7.org/fhir/ValueSet/package-material from the FHIR Standard
PackagedProductDefinition.packaging.property.type	example	Pattern: SPLCMBPRDTP http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
PackagedProductDefinition.packaging.property.value[x]	required	SPLComboProductType http://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductType from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	PackagedProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	PackagedProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	PackagedProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 3 elements(3 nested mandatory elements)
Must-Support: 16 elements

Structures

This structure refers to these other structures:

• SubmittedMedicinalProduct (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct)
• SubmittedManufacturedItem (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf

Maturity: 1

Other representations of profile: CSV, Excel, Schematron